The Effect of 8 Weeks Intake of a Probiotic Strain on a 6 Week Aspirin-induced Intestinal Deterioration Challenge in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled, Two Armed, Parallel Group Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Lewis score from capsule endoscopy
研究概览
简要总结
This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of daily intake of a probiotic strain versus placebo when co-administered to daily intake of 300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to attenuate and/or reverse Aspirin-induced deterioration of the small intestine.
详细描述
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks, probiotic strain/placebo is given for two additional weeks to investigate the potential effects of the probiotic strain on intestinal healing after long-time Aspirin use.
Subjects will participate in the trial for a total duration of 10 weeks including the run-in phase. Besides the screening visit, the trial will consist of 6 visits.
After having given their written informed consent, subjects will complete screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. After baseline assessments at Visit 2, subjects will start daily intake of 300mg Aspirin and also be randomly assigned to 8 weeks daily intake of active or placebo product in a ratio of 1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Healthy and without any gastrointestinal discomfort/pain symptoms
- •Age ≥ 18 - ≤ 40 years of both gender (aim of 1/3 of each gender in each arm)
- •Sedentary lifestyle (weekly training load below 2 hours within endurance sports)
- •Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
排除标准
- •Abdominal surgery which, as judged by the investigator, might affect the GI function (except appendectomy and cholecystectomy)
- •History of peptic ulcer disease
- •Any known bleeding disorder
- •Allergy to Aspirin
- •History of H. pylori disease
- •Resting diastolic blood pressure ≥ 90 mmHg
- •Resting systolic blood pressure ≥ 140 mmHg
- •A current diagnosis of psychiatric disease
- •Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months
- •BMI > 27
- •Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (Aspirin, Ibuprofen, Diclofenac, Naproxen, Celecoxib, Mefenamic acid, Etoricoxib, Indometacin)
- •Usage of medications, except contraceptives, in the last 2 weeks prior to screening
- •Diagnosed inflammatory gastrointestinal disease and/or irritable bowel syndrome
- •Lactose intolerance
- •Any other disease that, by the Investigators discretion, could interfere with the intestinal barrier function of the subject
- •Participation in other clinical trials in the past 2 months prior to screening
- •Regular use of probiotics in the last 2 months
- •Smoking and/or frequent use of other nicotine products
- •Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial
- •Use of laxatives, anti-diarrheals, anti-cholinergics and PPI within last 2 months prior to screening
- •Use of immunosuppressant drugs within last 4 weeks prior to screening
- •For Women: Pregnancy or lactation
研究组 & 干预措施
probiotic strain
Active arm treated with the probiotic strain for 8 weeks.
干预措施: probiotic strain (Dietary Supplement)
Placebo
Placebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Lewis score from capsule endoscopy
时间窗: 8 weeks
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy Lewis score between Visit 2 (randomization) and Visit 7 (end of treatment).
次要结局
- Blood I-FABP concentration(8 weeks)
- Mucosal ulcer number(8 weeks)
- Pain module score of the GSRS questionnaire(8 weeks)
- Total score of the GSRS questionnaire(8 weeks)
- Mucosal red spots number(8 weeks)
- Feces Calprotectin concentration.(8 weeks)
- blood Calprotectin concentration(8 weeks)